干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology)(Interferon alfa-2b biosimilar(Center For Genetic Engineering And Biotechnology))

概要

基本信息

药物类型

干扰素、生物类似药

别名

Heberon Alfa R、Inrec

靶点

IFNAR

作用机制

IFNAR激动剂(干扰素α/β受体复合体激动剂)、免疫刺激剂、先天性抗病毒免疫应答诱导剂

治疗领域

感染

在研适应症

病毒感染

非在研适应症-

原研机构

Centro de Ingenieria Genetica y Biotecnologia

在研机构

Heber Biotec SA

非在研机构-

最高研发阶段批准上市

首次获批日期

古巴 (2000-12-01),

病毒感染

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 26333714

当前序列信息引自: *****

关联

13

项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的临床试验

NCT04093323

/ Recruiting临床2期IIT

A Phase II Study of Type-1 Polarized Dendritic Cell (aDC1) -Based Treatment in Combination With Tumor-Selective Chemokine Modulation (CKM: Interferon Alpha 2b, Rintatolimod and Celecoxib) in Melanoma Patients With Primary PD-1/PD-L1 Resistance

This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.

开始日期2024-11-13

申办/合作机构

Roswell Park Comprehensive Cancer Center

[+1]

NCT04379518

/ Suspended临床1/2期IIT

Phase 1/2A Study of Rintatolimod and IFN Alpha Regimen in Cancer Patients With COVID-19

This phase I/IIa trial studies the best dose and side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.

开始日期2020-11-17

申办/合作机构

Roswell Park Comprehensive Cancer Center

[+1]

NCT03899987

/ Suspended临床2期IIT

Randomized Phase 2 Study: Neoadjuvant Conditioning of Prostate Cancer Tumor Microenvironment Using a Novel Chemokine-Modulating Regimen

This phase II trial studies how well aspirin and rintatolimod with or without interferon-alpha 2b work in treating patients with prostate cancer before surgery. Aspirin may help to keep the prostate cancer from coming back. Rintatolimod may stimulate the immune system and interfere with the ability of tumor cells to grow and spread. Interferon-alpha 2b may improve the body's natural response to infections and may slow tumor growth. It is not yet known how well rintatolimod, aspirin, and interferon-alpha 2b work in treating patients with prostate cancer undergoing surgery.

开始日期2019-11-29

申办/合作机构

Roswell Park Comprehensive Cancer Center

[+1]

100 项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的临床结果

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100 项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的转化医学

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100 项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的专利（医药）

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4

项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的文献（医药）

2020-12-01·Journal of Interferon & Cytokine Research

Therapeutic Effectiveness of Interferon Alpha 2b Treatment for COVID-19 Patient Recovery

Article

作者: González, Daniel ; Pereda, Ricardo ; Betancourt, Julio Roberto ; Rivero, Hubert Blas ; Nodarse, Hugo ; Domínguez, Rodolfo Emilio ; Mezquia, Natacha ; Venegas, Rafael ; Lopez, Lissette Del Rosario ; Rivero, Juan Carlos ; Pérez, Albadio

A previous report on 814 patients who were coronavirus disease 2019 (COVID-19) positive provided preliminary therapeutic efficacy evidence with interferon-α2b (IFN-α2b) in Cuba, from March 11 to April 14, 2020. This study re-evaluates the effectiveness of IFN-α2b during the period from March 11 to June 17, 2020. Patients received a combination of oral antivirals (lopinavir/ritonavir and chloroquine) with intramuscular or subcutaneous administration of IFN-α2b. The primary endpoint was the proportion of patients discharged from the hospital; the secondary endpoint was the case fatality rate, and several outcomes related to time variables were also evaluated. From March 11 to June 17, 2,295 patients had been confirmed to be severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive in Cuba, 2,165 were treated with Heberon^® Alpha R, and 130 received the approved protocol without IFN. The proportion of fully recovered patients was higher in the IFN-treated compared with the non-IFN-treated group. Prior IFN treatment decreases the likelihood of intensive care and increases the survival after severe or critical diseases. Benefits of IFN were significantly supported by time variables analyzed. This second report confirmed our preliminary evidence about the therapeutic effectiveness of IFN-α2b in SARS-CoV-2 infection and postulated Heberon Alpha R as the main component within antiviral drugs used in the Cuban protocol COVID-19.

2020-09-01·Journal of Interferon & Cytokine Research4区 · 医学

Therapeutic Effectiveness of Interferon-α2b Against COVID-19: The Cuban Experience

4区 · 医学

Article

作者: González, Daniel ; López, Lissette Del Rosario ; Pereda, Ricardo ; Betancourt, Julio Roberto ; Rivero, Hubert Blas ; Domínguez, Rodolfo Emilio ; Mezquia, Natacha ; Venegas, Rafael ; Rivero, Juan Carlos ; Pérez, Albadio

A prospective observational study was conducted for assessing the therapeutic efficacy of interferon (IFN)-α2b in patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the first month after the coronavirus disease 2019 (COVID-19) outbreak began in Cuba. From March 11th to April 14th, 814 patients were confirmed SARS-CoV-2 positive in Cuba. Seven hundred sixty-one (93.4%) were treated with a combination of oral antivirals (lopinavir/ritonavir and chloroquine) with intramuscular administration of IFN-α2b (Heberon^® Alpha R, Center for Genetic Engineering and Biotechnology, Havana, Cuba), 3 times per week, for 2 weeks. Fifty-three patients received the approved COVID protocol without IFN treatment. The proportion of patients discharged from hospital (without clinical and radiological symptoms and nondetectable virus by real-time polymerase chain reaction) was higher in the IFN-treated compared with the non-IFN treated group (95.4% vs. 26.1%, P < 0.01). The case fatality rate (CFR) for all patients was 2.95%, and for those patients who received IFN-α2b the CFR was reduced to 0.92. Intensive care was required for 82 patients (10.1%), 42 (5.5%) had been treated with IFN. This report provides preliminary evidence for the therapeutic effectiveness of IFN-α2b for COVID-19 and suggests that the use of Heberon Alpha R may contribute to complete recovery of patients.

2004-01-01·Drugs in R & D4区 · 医学

Bioequivalence of Two Recombinant Interferon ??-2b Liquid Formulations in Healthy Male Volunteers

4区 · 医学

ArticleOA

作者: Armando Correa-Fernandez ; Jorge Ducongé ; Idrian Garcia-Garcia ; Lourdes Olivera-Ruano ; Francisco Hernandez-Bernal ; Carmen Valenzuela-Silva ; Majel Cervantes-Llano ; Joel Ferrero-Bibilonia ; Carlos Alberto Gonzalez-Delgado ; Pedro Lopez-Saura ; Ramon Soto-Hernandez

OBJECTIVEInterferon (IFN) alpha-2b is a protein with antiviral, antiproliferative and immunoregulatory properties that is approved for several clinical indications. A new liquid, albumin-free, IFNalpha-2b formulation has recently been developed. This study aimed to evaluate the equivalence of the pharmacokinetic, pharmacodynamic and safety properties of the new formulation with a reference one in healthy male volunteers.METHODSA randomised, crossover, double-blind study with a 3-week washout period was performed in which Heberon Alfa R (formulation A) and Viraferon (formulation B) were compared. A single 20 x 10(6) IU IFNalpha-2b dose was administered subcutaneously to 14 apparently healthy male subjects. Serum IFN level was measured over 48 hours by enzyme immunoassay (EIA) and by antiviral activity titration. Clinical and laboratory variables were determined, as were pharmacodynamic and safety criteria.RESULTSGroups were homogeneous with regard to all demographic and baseline variables. Pharmacokinetic comparison by EIA did not show differences between the formulations: area under the curve (AUC) 2572 versus 2561 ng x h/L, maximum plasma concentration (Cmax) 318 versus 354 ng/L, time to Cmax (tmax) 8.2 versus 8.5 h, elimination half-life (t(1/2)) 5.87 versus 6.08 h, terminal elimination rate (lambda) 0.122 versus 0.118 h(-1), and mean residence time (MRT) 10.9 versus 12.0 h for formulations A and B, respectively. The differences never reached 20%, which is the clinically significant threshold. The 90% confidence interval of the ratio between them was in all cases within the 0.8, 1.25 range. The two formulations were clinically equivalent with regard to serum IFN antiviral activity titration (0.8, 1.25 criterion) regarding their pharmacokinetic parameters. There were no significant differences with respect to the pharmacodynamic variables: serum beta2-microglobulin and temperature increase. Heart rate and blood pressure changes did not differ either. Both products provoked similar haematological count decreases and had similar safety profiles. The most frequent adverse reactions were fever, tachycardia, headache and arthralgias.CONCLUSIONThe overall analysis strongly suggests the bioequivalence of these two products.

100 项与干扰素α-2b生物类似药(Center For Genetic Engineering And Biotechnology) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB05	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
病毒感染	古巴	-	2000-12-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03403634 (CTgov)	临床2期	肝转移 \| 复发性结直肠癌 \| 结直肠癌	19	Laboratory Biomarker Analysis+Intron A+Heberon Alfa+Urifron+Rintatolimod+Celecoxib	衊廠襯構衊蓋顧糧壓鏇(鹹蓋鏇糧選夢獵觸膚繭) = 衊憲艱網壓窪願構繭顧艱鬱膚積襯夢齋鹽蓋願 (願鬱衊夢選網範餘鏇壓, 製繭衊醖觸鏇積廠憲積 ~ 鬱網鏇廠鑰齋觸構積鏇) 更多	-	2022-03-02
NCT01460875 (CTgov)	N/A	皮肤黑色素瘤	34	laboratory biomarker analysis+Intron A+Heberon Alfa	糧餘構範鹽蓋艱選構鑰(廠願艱襯餘鏇網夢顧簾) = 窪蓋鬱憲鬱襯網顧繭鏇鹽廠遞獵廠製襯積齋艱 (範築築網積願網衊範觸, 鏇選範蓋夢鏇壓製願憲 ~ 願鬱醖艱築顧鏇鹽窪鹹) 更多	-	2018-11-02
NCT00126594 (CTgov)	临床2期	转移性肾细胞癌	80	Laboratory Biomarker Analysis+Sorafenib Tosylate (Sorafenib Tosylate)	膚願願範顧願鏇夢廠築(選廠齋壓糧淵構製廠鹽) = 築廠糧鏇遞廠膚顧餘築衊膚齋鹹鑰淵壓簾鹹醖 (餘膚鏇簾襯醖觸繭襯獵, 網鹹網膚鑰廠艱廠願鑰 ~ 鬱繭膚壓鑰範願顧鹹鑰) 更多	-	2016-09-16
NCT00126594 (CTgov)	临床2期	转移性肾细胞癌	80	Laboratory Biomarker Analysis+Sch 30500+Heberon Alfa+Urifron+Sorafenib Tosylate (Sorafenib Tosylate, Recombinant Interferon Alfa-2b)	膚願願範顧願鏇夢廠築(選廠齋壓糧淵構製廠鹽) = 齋膚鹽窪糧衊壓製製繭衊膚齋鹹鑰淵壓簾鹹醖 (餘膚鏇簾襯醖觸繭襯獵, 醖願窪遞鏇餘遞襯構憲 ~ 願繭衊蓋窪簾憲鏇餘衊) 更多	-	2016-09-16